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Reporting of planned statistical methods in published surgical randomised trial protocols: a protocol for a
Kim Madden1, Erika Arseneau1, Nathan Evaniew2
1Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
This systematic review assesses the reporting quality of statistical methods in surgical randomized controlled trial (RCT) protocols using SPIRIT guidelines. Findings will guide improvements in surgical research reporting.
Area of Science:
- Medical Research
- Surgical Trials
- Health Informatics
Background:
- Poor reporting in health research leads to data misrepresentation and misinformation.
- The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Group provides guidelines for protocol reporting.
- Improving the quality of reporting in surgical randomized controlled trials (RCTs) is crucial for reliable research.
Purpose of the Study:
- To conduct a systematic review of published surgical RCT protocols.
- To assess the reporting quality and completeness of statistical aspects in these protocols.
- To identify deficiencies in reporting and inform recommendations for improvement.
Main Methods:
- Systematic literature search of MEDLINE, EMBASE, and CENTRAL for surgical RCT protocols.
- Independent review and data extraction by author pairs using a structured form.
- Assessment of statistical reporting quality based on SPIRIT guidelines.
Main Results:
- The review will quantify the quality of statistical reporting in surgical RCT protocols.
- Identified deficiencies will highlight areas needing improvement in protocol development and reporting.
- Results will provide evidence-based insights into current reporting standards.
Conclusions:
- The study will elucidate the current state of statistical reporting in surgical RCT protocols.
- Findings will inform surgeons, researchers, and editors on enhancing reporting quality.
- Recommendations will aim to rectify common deficiencies and improve the integrity of surgical research.
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